Allergan’s Biocell ALCL Risk Leads Regulators Worldwide To Target Breast Implant Design

For several years, medical device regulators and health researchers worldwide have tried to gain a better understanding about the rare form of cancer now known as breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL), which has been increasingly linked to one-particular textured design: Allergan’s Biocell implant.

On January 26, 2011, the FDA first released a report about case studies and epidemiological research that suggested there was a link between breast implants and ALCL, identifying cases of the rare cancer that developed in the tissue surrounding large surface area, textured implants.

The agency then issued a statement about emerging information on the breast implant lymphoma problems in 2017, and a number of subsequent studies have confirmed that the breast implant ALCL cancer risk is real. However, the U.S. regulators have not identified a specific product.

In April, Canada and France became the first countries to ban the Allergan Biocell breast implant by name. On April 4, Health Canada issued a press release announcing it had suspended Allergan’s license to sell the Biocell in that country.

On the same day, French regulators announced a ban on Allergan textured breast implants nationwide, blocking the company from renewing its license to distribute its textured breast implants there. The ban came following a hearing in February, where French health experts specifically called for the Allergan Biocell implant to be removed from the market.

In both instances, regulators noted that a disproportionate number of breast implant lymphoma cases seemed to be related to the use of the macro-textured implant, and in the case of Canada, it was the only implant of that type sold in the country.

In Australia, regulators are currently investigating the risks and benefits of breast implants, and note that they are working closely with international monitors, specifically mentioning Canada’s ban on the Biocell as part of their deliberations.

To date, the Biocell appears to be the only implant repeatedly mentioned by regulators worldwide by name in connection to BIA-ALCL.

Breast Implant Cancer Risks

In June 2017, a study published in the medical journal Plastic and Reconstructive Surgery suggested that certain textured breast implants may increase the risk of anaplastic large cell lymphoma anywhere from 10 to 14 times, when compared to smooth breast implants.

Another study, published in October 2017, warned that many breast implant cancer cases worldwide have likely not been reported, and noted that doctors and patients may not be aware of BIA-ALCL.

In March 2018, the FDA indicated that it was aware of more than 400 cases of breast implant-related cancer.

A year later, in March 2019, the FDA held a two-day hearing on breast implant safety and benefits, revealing that it has received tens of thousands of reports of breast implant complications.

Despite growing concerns, the panel of FDA advisers decided against recommending any breast implant recalls, indicating that it was too early to determine whether the risks were limited to specific breast implant designs.